Renewals and Revisions
The IRB generally grants approval for one year. If the researcher would like to extend the study beyond the initially approved period, he/she can submit a renewal application. Studies that have a change in personnel or protocol need to submit revised applications to the IRB for approval before continuing the study.
Reporting of Unanticipated Problems, Serious or Continuing Non-Compliance, and Suspensions or Terminations of IRB Approval
Investigators must immediately report any unanticipated adverse effects, events, other problems involving risks to subjects to the IRB Chair. The IRB Chair has the authority to suspend the research until a more thorough review can take place, may terminate IRB approval and require the study to be closed (with appropriate protections for avoiding harm to enrolled participants), or require further training for the investigator as a condition of approval for future research.
When unanticipated adverse effects pose a significant risk to participants, the IRB chair must report such events to the vice president for academic affairs who may be required to contact the sponsors of the research and/or the Office of Human Subject Research Protection. The IRB Chair is also responsible for reporting serious non-compliance.
The Institutional Review Board will deny a research application if it believes the risks outweigh the benefits of the research.
If the investigator disagrees with the Board’s decision, the researcher may send a letter of appeal and any other pertinent information to the IRB chair. Appeal requests are considered by the entire board. The decision of the IRB is delivered in writing and via email to the investigator. If the appeal application is not approved, the research cannot be conducted.
If a researcher questions the conduct of the IRB or believes that his/her appeal was unfairly denied, he/she may appeal directly to the vice president for academic affairs.